FDA Drug recall D-1185-2018
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical,…
- FDA Drug
- Class III
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class III recall of Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical,… by Par Pharmaceutical, citing failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1185-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-09-06 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Par Pharmaceutical |
| Distribution | US |
Product
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
Reason
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Identifiers
| code_info | Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Par Pharmaceutical
- BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
FDA Drug · Class II · 2020-09-02 · Par Pharmaceutical - Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par F…
FDA Drug · Class II · 2020-04-08 · Par Pharmaceutical - PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
FDA Drug · Class III · 2020-03-25 · Par Pharmaceutical - Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services…
FDA Drug · Class III · 2020-02-19 · Par Pharmaceutical - Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977…
FDA Drug · Class I · 2019-05-15 · Par Pharmaceutical
All Par Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1185-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.